CTRI/2026/02/103386已完成不适用
An Open Label Balanced Randomized Single Ascending Dose Study To Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid EPA and Calcium L 5 Methyltetrahydrofolate L 5 MTHF Following Oral Administration Of Different Dose Levels of Creneuros CNS Fish Oil Plus Softgels Supplied By Sichuan Credit Pharmaceutical Co Ltd China in Healthy Subjects Under Fasting Conditions
Sichuan Credit Pharmaceutical Co Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年2月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
At least 32 number of healthy, human subjects will be recruited to evaluate the Pharmacokinetic dose linearity in healthy subjects
Note A total of 32 subjects 8 subjects in each groups will be enrolled in this study
As per the discretion of the Investigator, a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 08 subjects in each cohorts during the study period
In study period each group subjects will be housed in the clinical facility for at least -60.00 hours pre-dose to 72.00 hours post dose
Dosing will be done individually for each cohort groups Cohort 01 Cohort 02 Cohort 03 Cohort 04
The subsequent group’s check in will be at the check out day of the previous group
In study period after an overnight fasting of at least 08.00 hours in the morning a single oral dose of the test product T will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature to the subjects sitting in upright posture under the supervision of the investigator or medical officer and/or trained study personnel including the quality assurance auditors or monitors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by 12-lead electrocardiogram ECG Chest X-Ray and clinical laboratory assessments Willing to consume ovo lacto vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel Non smokers Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide intrauterine device IUD with a low failure rate of less than 1 percentage per year or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active.
排除标准
- •Evidence of allergy or known hypersensitivity to Eicosapentaenoic Acid EPA and Calcium L-5-Methyltetrahydrofolate L 5 MTHF or its inactive ingredients.
- •Evidence of allergy to fish shellfish Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and caffeine-containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study Consumption of alcohol and its products grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study Subjects who have taken an unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check-in History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period Positive results for alcohol test prior to check-in of each period Any blood donation / excess blood loss within 90 days of check-in Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in Use of hormone replacement therapy for a Period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females likely to become pregnant during conduction of the study.
研究者
Dr Pradeep T
Spinos Lifescience and research private limited
研究点 (1)
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